Advanced hormono-dependent breast cancer MedDRA version: 10.1 Level: LLT Classification code 10006204 Term:
Conditions
Interventions
Product Code: AVE1642
Pharmaceutical Form: Solution for infusion
Current Sponsor code: AVE1642
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2-
Tra
Sponsors
sanofi-aventis recherche et développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Post-menopausal women (age = 60 years or history of bilateral oophorectomy or prior castration or age = 50 years amenorrheic with FSH > 50 IU/L ) who failed to no more than 2 prior anti-hormonotherapy • Histologically proven invasive breast adenocarcinoma with positive hormone receptor (ER+ and/or Pg+) (defined as = 10% tumor staining by IHC method) • Aromatase inhibitor as the last hormonal treatment • Histologically proven metastasis in case of a unique site • Measurable disease as per RECIST definition (longest diameter = 20mm using conventional technique or = 10 mm with spiral CT scan) • Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Methodology related: ? 2 ? Inadequate organ function: 1. Neutrophils (ANC) 1.5 ULN 5. ASAT ALAT > 2.5 ULN 6. Creatininemia > 1.5 ULN (or = 2.0 mg/dl) 7. INR > 1.6 ? HbA1c > 8% ? No measurable disease as defined by RECIST criteria ? Previous radiotherapy on the only measurable metastatic site ? History of cerebral metastasis symptomatic or not, leptomeningeal disease ? Patients with only bone metastasis, pleural effusion, ascitis or lung lymphangitis carcinomatosis ? No evidence of hormonosensitivity defined in the case of an early relapse (within the first 12 months during adjuvant therapy and in case of advanced disease setting as tumor response or stabilization for less than 12 weeks before progression). ? HER 2-neu positive tumor ? More than one prior regimen of chemotherapy for metastatic disease ? Prior exposure to fulvestrant or to anti IGF1-R compound ? Biphosphonate treatment initiated less than 1 week before study entry ? Any of the following within 6 months prior to enrollment: myocardial infarction, severe/ unstable angina, or coronary/peripheral artery bypass graft surgery, clinically symptomatic and uncontrolled cardiovascular disease, or clinically significant cardiac arrhytmias (grade 3-4) ? Other severe underlying medical conditions, which could impair the ability to participate in the study ? Patient unwilling and /or unable to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. • Related to the active comparator (fulvestrant): ? Known contraindication to fulvestrant: hypersensitivity to the active substance or to any of the excipients ? Anti-coagulant continuous treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objectives of the study are efficacy endpoints e.g. Progression Free Survival rate (PFSR) at 6 months and Progression Free Survival (PFS). Other secondary endpoints include safety (TEAEs, hematology, biochemistry parameters including glucose metabolism), detection of HAHA (human anti humanized antibodies), and potential pharmacokinetic interaction between AVE1642 and fulvestrant. Biological activity will be assessed on tumor tissue (ARNm) when possible. ;Primary end point(s): The primary efficacy endpoint is the clinical benefit that is defined as a confirmed complete response (CR) or a confirmed partial response (PR) or a stable disease (SD) lasting at least 24 weeks (6 cycles), during the treatment period as defined by the RECIST criteria and assessed by an Independent Radiological Review Committee (IRRC). ;Main Objective: The primary objective of the study is to evaluate the clinical efficacy of AVE1642 in combination with fulvestrant in terms of clinical benefit (CB) rate defined as the rate of complete responses (CR) + partial responses (PR) + the rate of stable disease (SD) lasting at least 24 weeks, in female patients with advanced hormonodependent breast cancer. | — |
Countries
France, Italy, Spain
Outcome results
None listed